“The extension of the transitional period and the removal of the “date of sell” provision in MDR.”
The goal of MDR/IVDR - The amendment to regulations (EU) 2023/607 for the revision of MDR and IVDR aims to ensure a high level of public health protection, including patient safety and the avoidance of medical device shortfalls necessary for the smooth running of medical services, without compromising the current quality or safety requirements. To this end, manufacturers and notified bodies have sufficient time to conduct conformity assessments of devices covered by certificates or declarations of conformity issued under directive 90/385/EEC or directive 93/42/EEC in accordance with the MDR. In addition, the "date of sale" is removed from the MDR and IVDR to prevent unnecessary disposal of safe equipment.
In Article 120(4) of the MDR and Article 110(4) of the IVDR, the deadline for...